Vaccines are usually very slow to go to market. There are many good reasons for this, foremost among them the safety of the people who are being asked to be the vaccine’s early adopters. This is where we find ourselves today with the COVID-19 vaccine, as the Food and Drug Administration (FDA) has just issued the first Emergency Use Authorization to allow a vaccine to be immediately distributed to prevent COVID-19.
Any new vaccine is going to cause injuries – this is simply the way the introduction of products that protect people against dangerous and deadly diseases works.
In response to this reality, Canada has already introduced a national compensation scheme to compensate people injured by the COVID-19 vaccine. The Canadian federal government is guaranteeing that anyone who experiences an adverse reaction to the vaccine or sustains a more lasting injury will receive full compensation.
While national injury compensation schemes aren’t anywhere near as much a part of our legal DNA here in the United States, it is something that our federal government is about to try.
Any claims of injuries related to a COVID-19 vaccine will be directed to the Countermeasures Injury Compensation Program, being run by the U.S. Department of Health and Human Services (HHS).
This is a federal program that is almost never used but will be for COVID-19 claims. Earlier this year, Congress set aside $30 billion worth of funding for HHS but it remains unclear how much of that money will go into this compensation scheme, which was set up to encourage drugmakers to help combat public health emergencies.
Proponents of the idea say that it is a necessary catalyst of innovation by protecting pharmaceutical companies that make vaccines from potentially very expensive liability lawsuits. Under the scheme, in a practical sense, these lawsuits will be paid by taxpayers.
Others are far less enthusiastic, arguing that this barring of claims in favor of the Countermeasures Injury Compensation Program will never actually work because the dollar amount of the claims that are going to come will dramatically exceed the amount of money the program will ever have.
This is further complicated at the moment by the fact that it has been too early for HHS to receive any COVID-19 vaccine injury claims and the compensation program hasn’t yet asked for funding. Layer on top of this the reality that one-third of the $30 billion Congress authorized for this scheme has already been awarded for development of treatments and vaccines, as well as other related research.
In a recent article in the New England Journal of Medicine, Sam Halabi, J.D., Andrew Heinrich, J.D., and Saad B. Omer, M.B., B.S., Ph.D., M.P.H., acknowledge that the best-laid vaccine plans are going to have complications, especially where they have been rushed to market. The authors point out that:
For a vaccine that will most likely be distributed worldwide, there is an inevitable risk of serious adverse events, such as seizures and allergic reactions, even with a very safe product. Such events might not begin surfacing until a substantial number of people have been vaccinated. During the 2009 H1N1 influenza pandemic, the incidence of serious adverse events after immunization varied by country.
The authors raise another critically important point – the uncertainty of compensation costs because of our inability to predict how these early vaccines with fare as compared with other early vaccines.
“In the United States, the Vaccine Adverse Event Reporting System received reports…at a rate of 2.45 per 100,000 doses. China’s equivalent surveillance system found that 1083 of the 8067 adverse events recorded (1.21 per 100,000 doses) were serious. Compensation costs also varied. One H1N1 vaccine that contained an adjuvant was associated with an increased risk of narcolepsy, which resulted in substantial compensation claims in Northern European countries,” the authors of the article noted.
No matter the good intentions behind the HHS scheme, the reality is that Americans who are injured by the COVID-19 vaccines the federal government has been in a hurry to help pharmaceutical companies develop are going to have a very hard time receiving the compensation they deserve.
Originally from Boston, John K. Lawlor received his B.A. from Barry University in Miami and his law degree from Nova Southeastern University in 1994. After trying cases at a local litigation firm in South Florida, Lawlor opened his own practice in 1996, and, in 1998, began what is now the Law Firm of Lawlor, White & Murphey. Lawlor’s areas of focus include complex personal injury, medical malpractice, and wrongful death cases. He spearheads the firm’s litigation and trial practice division. He is admitted to practice before all Florida courts and the United States 11th Circuit Court of Appeals.